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NCT04290611 Clinical Trial

a Vigibase Pharmacovigilance Study of ENzalutamide Drug-induced neurotoxicitY

Prostate Cancer Clinical Trial

— VENDY  

Official title:
Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04290611
Other study ID # CIC1421-20-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date April 8, 2023

Study information
Verified date April 2023
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

Description:

Enzalutamide are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with enzalutamide

Recruitment information / eligibility
Status Completed
Enrollment 500000
Est. completion date April 8, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2020 Adverse events reported were including any MedDRA terms Patients treated with enzalutamide reported in the WHO database. Exclusion Criteria: - Chronology not compatible between the drug and the toxicity

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Enzalutamide
Enzalutamide for the treatment of prostate cancer or other solid tumors

Locations
Country Name City State
France Centre d'Investigation Clinique Hôpital Pitié-Salpêtrière Paris

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients with neurological adverse events with significant over-reporting enzalutamide Identification and report of neurological toxiciy of enzalutamdie Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
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